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Med."],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Autism spectrum disorder (ASD) can be reliably diagnosed at 18 months, yet significant diagnostic delays persist in the United States. This double-blinded, multi-site, prospective, active comparator cohort study tested the accuracy of an artificial intelligence-based Software as a Medical Device designed to aid primary care healthcare providers (HCPs) in diagnosing ASD. The Device combines behavioral features from three distinct inputs (a caregiver questionnaire, analysis of two short home videos, and an HCP questionnaire) in a gradient boosted decision tree machine learning algorithm to produce either an ASD positive, ASD negative, or indeterminate output. This study compared Device outputs to diagnostic agreement by two or more independent specialists in a cohort of 18\u201372-month-olds with developmental delay concerns (425 study completers, 36% female, 29% ASD prevalence). Device output PPV for all study completers was 80.8% (95% confidence intervals (CI), 70.3%\u201388.8%) and NPV was 98.3% (90.6%\u2013100%). For the 31.8% of participants who received a determinate output (ASD positive or negative) Device sensitivity was 98.4% (91.6%\u2013100%) and specificity was 78.9% (67.6%\u201387.7%). The Device\u2019s indeterminate output acts as a risk control measure when inputs are insufficiently granular to make a determinate recommendation with confidence. If this risk control measure were removed, the sensitivity for all study completers would fall to 51.6% (63\/122) (95% CI 42.4%, 60.8%), and specificity would fall to 18.5% (56\/303) (95% CI 14.3%, 23.3%). Among participants for whom the Device abstained from providing a result, specialists identified that 91% had one or more complex neurodevelopmental disorders. No significant differences in Device performance were found across participants\u2019 sex, race\/ethnicity, income, or education level. For nearly a third of this primary care sample, the Device enabled timely diagnostic evaluation with a high degree of accuracy. The Device shows promise to significantly increase the number of children able to be diagnosed with ASD in a primary care setting, potentially facilitating earlier intervention and more efficient use of specialist resources.<\/jats:p>","DOI":"10.1038\/s41746-022-00598-6","type":"journal-article","created":{"date-parts":[[2022,5,5]],"date-time":"2022-05-05T10:08:32Z","timestamp":1651745312000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":90,"title":["Evaluation of an artificial intelligence-based medical device for diagnosis of autism spectrum disorder"],"prefix":"10.1038","volume":"5","author":[{"given":"Jonathan T.","family":"Megerian","sequence":"first","affiliation":[]},{"given":"Sangeeta","family":"Dey","sequence":"additional","affiliation":[]},{"given":"Raun D.","family":"Melmed","sequence":"additional","affiliation":[]},{"given":"Daniel L.","family":"Coury","sequence":"additional","affiliation":[]},{"given":"Marc","family":"Lerner","sequence":"additional","affiliation":[]},{"given":"Christopher J.","family":"Nicholls","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0588-8742","authenticated-orcid":false,"given":"Kristin","family":"Sohl","sequence":"additional","affiliation":[]},{"given":"Rambod","family":"Rouhbakhsh","sequence":"additional","affiliation":[]},{"given":"Anandhi","family":"Narasimhan","sequence":"additional","affiliation":[]},{"given":"Jonathan","family":"Romain","sequence":"additional","affiliation":[]},{"given":"Sailaja","family":"Golla","sequence":"additional","affiliation":[]},{"given":"Safiullah","family":"Shareef","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1677-2158","authenticated-orcid":false,"given":"Andrey","family":"Ostrovsky","sequence":"additional","affiliation":[]},{"given":"Jennifer","family":"Shannon","sequence":"additional","affiliation":[]},{"given":"Colleen","family":"Kraft","sequence":"additional","affiliation":[]},{"given":"Stuart","family":"Liu-Mayo","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8394-1505","authenticated-orcid":false,"given":"Halim","family":"Abbas","sequence":"additional","affiliation":[]},{"given":"Diana E.","family":"Gal-Szabo","sequence":"additional","affiliation":[]},{"given":"Dennis P.","family":"Wall","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2108-2490","authenticated-orcid":false,"given":"Sharief","family":"Taraman","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2022,5,5]]},"reference":[{"key":"598_CR1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.15585\/mmwr.ss6904a1","volume":"69","author":"MJ Maenner","year":"2020","unstructured":"Maenner, M. 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Dr. Carpenter, Dr. Lajonchere, Dr. Lerner, Dr. Megerian, Dr. Nicholls, and Dr. Ostrovsky have received consulting fees from Cognoa. Dr. Constantino serves on the Advisory Board for Cognoa. Dr. Coury has received consulting fees from BioRosa, Cognoa, Quadrant Biosciences, and Stalicla and receives research support from Autism Speaks and Quadrant Biosciences. Dr. Sohl has received consulting fees from Cognoa, is on the Medical Advisory Board for Quadrant Biosciences, and provides research support for Autism Speaks. Mr. Abbas, Dr. Kraft, Mr. Liu-Mayo, Dr. Shannon, and Dr. Taraman are employees of Cognoa and have Cognoa stock options. Dr. Taraman additionally receives consulting fees for Cognito Therapeutics, volunteers as a board member of the AAP\u2014OC chapter and AAP\u2014California, is a paid advisor for MI10 LLC, and owns stock for NTX, Inc., and HandzIn. Dr. Kraft is also a consultant for SOBI, Inc. and Happiest Baby, Inc., and serves on the Advisory Board for DotCom Therapy. Dr. Wall is the co-founder of Cognoa, is on the board of directors, and holds Cognoa stock. Dr. Gal-Szabo is an independent contractor for Cognoa. Drs. Dey, Melmed, Rouhbakhsh, Narasimhan, Romain, Golla, and Shareef have no conflicts of interest to disclose.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"57"}}